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Non-Invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan

NCT03165201 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 131

Last updated 2021-04-29

No results posted yet for this study

Summary

This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver transplant recipients, designed in accordance with the STARD criteria.

Study participants are 200 patients with liver transplant, due to undergo liver biopsy as part of serial evaluation of their liver health and to rule out rejection. The whole study will take 3 years with 2 years of recruitment The main aim is to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.

Conditions

  • Liver Transplantation

Interventions

DEVICE

LiverMultiScan

We will study participants who are due to be evaluated for possible liver transplant rejection. There will be no change to usual care as part of the study, but patients will get an additional MRI scan, so that the results can be compared to the biopsy results. Each centre has a consultant radiologist specialising in liver imaging with experience in post-transplant review; the radiologist will review the MRI scans and inform the patient's doctor if any structural liver abnormalities are found (e.g. abnormal vessels, haemangiomas, tumours or cysts) as this may have implications for the patient's planned biopsy.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • University of Coimbra

    collaborator OTHER

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Perspectum

    lead INDUSTRY

Principal Investigators

  • Minneke Coenraad, MD · Leiden University Medical Centre

  • Emer Fitzpatrick, MD · King's College Hospital NHS Trust

Eligibility

Min Age
6 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2020-08-01
Completion
2020-10-01

Countries

  • Netherlands
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03165201 on ClinicalTrials.gov